{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-03-18", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Ongoing", "city": "North Haven", "state": "CT", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "91324", "recalling_firm": "Covidien, LP", "address_1": "60 Middletown Ave", "address_2": "N/A", "postal_code": "06473-3908", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe", "recall_number": "Z-1176-2023", "product_description": "Sofsilk Coated Braided Silk Suture Product Description\t\t\t\t\t\t\t\t\t CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36\tCS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36\tCS490 CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36\tCS562 GS-823 SOFSILK* 2-0 BLK 75CM V30 X36\tGS823 GS-835 SOFSILK* 1 BLK 75CM V20 X36\tGS835 S-1172 SOFSILK* 6-0 BLK 45CM C1 X36\tS1172 S-1173 SOFSILK* 5-0 BLK 45CM C1 X36\tS1173 S-1174 SOFSILK* 4-0 BLK 45CM C1 X36\tS1174 S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12\tS1750K S-176 SOFSILK* 0 BLK 12X45CM PCT X24\tS176 S-176 SOFSILK* 0 BLK 12X45CM PCT X24\tS176 S-1768K SOFSILK* 7-0 BLK 45CM HE6 DAX12\tS1768K S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36\tS182 S-183 SOFSILK* 4-0 BLK 12X45CM PCT X36\tS183 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36\tS184 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36\tS185 S-187 SOFSILK* 1 BLK 6X45CM PCT X36\tS187 S-206 SOFSILK* 2 BLK 100CM STDLTH X36\tS206 S-243 SOFSILK* 4-0 BLK 12X60CM PCT X36\tS243 S-244 SOFSILK* 3-0 BLK 12X60CM PCT X36\tS244 S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36\tS245 S-246 SOFSILK* 0 BLK 6X60CM PCT X36\tS246 S-2782K SOFSILK* 4-0 WHI 45CM SS24 DA\tS2782K S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36\tS303 S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36\tS304 S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36\tS305 S-316 SOFSILK* 0 BLK 12X75CM PCT X24\tS316 S-317 SOFSILK* 1 BLK 12X75CM PCT X24\tS317 S-318 SOFSILK* 2 BLK 12X75CM PCT X24\tS318 S-346 SOFSILK* 0 BLK 12X60CM PCT X24\tS346 S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36\tS605 S-607 SOFSILK* 1 BLK 2X150CM PCT X36\tS607 S-608 SOFSILK* 2 BLK 2X150CM PCT X36\tS608 SS-523 SOFSILK* 2-0 BLK 75CM SC1 X36\tSS523 SS-525 SOFSILK* 1 BLK 75CM SC1 X36\tSS525 SS-5641 SOFSILK* 4-0 BLK 45CM P13 X36\tSS5641 SS-5641G SOFSILK* 4-0 BLK 45CM P13 X12\tSS5641G SS-5678 SOFSILK* 5-0 BLK 45CM P11 X36\tSS5678 SS-5684 SOFSILK* 3-0 BLK 45CM P14 X36\tSS5684 SS-623 SOFSILK* 2-0 BLK 75CM SC2 X36\tSS623 SS-645 SOFSILK* 4-0 BLK 75CM C12 X36\tSS645 SS-653 SOFSILK* 4-0 BLK 75CM C13 X36\tSS653 SS-673 SOFSILK* 5-0 BLK 75CM C12 X36\tSS673 SS-683G SOFSILK* 4-0 BLK 45CM C13 X12\tSS683G SS-685G SOFSILK* 2-0 BLK 45CM C15 X12\tSS685G SS-686 SOFSILK* 4-0 BLK 45CM C12 X12\tSS686 SS-689 SOFSILK* 1 BLK 75CM C16 X36\tSS689 SS-745 SOFSILK* 3-0 BLK 75CM C12 X36\tSS745 SS-786 SOFSILK* 0 BLK 75CM C14 X36\tSS786 SS-787 SOFSILK* 1 BLK 75CM C14 X36\tSS787 VS-533 SOFSILK* 2-0 BLK 90CM V20 DAX36\tVS533 VS-845 SOFSILK* 1 BLK 75CM V26 X36\tVS845 VS-870 SOFSILK* 5-0 BLK 75CM CV23 X36\tVS870 VS-871 SOFSILK* 4-0 BLK 75CM CV23 X36\tVS871 SOFSILK 4-0 30 BK CV-23 VS871-2\tVS8712 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36\tVS872 SOFSILK 3-0 30 BK CV-23 VS872-2\tVS8722 VS-882 SOFSILK* 3-0 BLK 75CM CV15 X36\tVS882 SOFSILK 5-0 30 BK CV-11 VS890-2\tVS8902 XX-5278 SOFSILK* 3-0 BLK 150CM PCT X36\tXX5278 XX-5280 SOFSILK* 0 BLK 150CM PCT X36\tXX5280 XX-5281 SOFSILK* 1 BLK 150CM PCT X36\tXX5281 XX-5284 SOFSILK* 4 BLK 150CM PCT X36\tXX5284", "product_quantity": "271800 units", "reason_for_recall": "Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact", "recall_initiation_date": "20221202", "center_classification_date": "20230225", "report_date": "20230308", "code_info": "GTIN: 20884521086781, 20884521758060, 20884521088136, 20884521088525, 20884521087504, 20884521085289, 20884521087672, 20884521087481, 20884521090566, 20884521086712, 20612479214235, 10884521084698, 20884521084695, 20884521085166, 20884521087580, 10884521087583, 20884521089256, 20884521088532, 20884521087719, 20884521090160, 10884521090163, 20884521087900, 20612479214419, 20884521083629, 20884521085944, 20884521086668, 20884521087399, 10884521086142, 20884521086149, 10884521086623, 20884521086620, 20884521106106, 20884521085968, 20884521086484, 20884521086491, 10884521086494, 20884521088624, 10884521086661, 20884521086170, 20884521085951, 10884521086463, 20884521086460, 20884521086187, 10884521085787, 20884521085784, 20884521085517, 20884521090184, 20612479214495, 20884521090153, 20884521086651, 10884521085510, 20884521088464, 20884521088129, 20884521086194, 10884521086197, 20884521086552, 10884521087484, 20884521085982, 10884521085985, 20884521086477, 20884521106021, 20884521106052, 20884521757926, 10884521083622, 20612479213283, 20884521090115, 10884521090118, 20884521085746, 20884521087429, 20884521086774, 20884521085975, 20884521088143, 20884521086705, 20884521085470, 20884521085500, 20884521084671, 10884521084674, 20884521758039, 20612479213269, 10884521085169, 20884521086514, 20884521086200, 20884521106045, 20884521085739, 20884521086422. Model Number Lot # CS211 D1L1576Y D2B0747Y CS490 D2C2519Y CS562 D1G1928Y GS823 D1K1923Y D2D1396Y GS835 D1E1757Y S1172 D2C2304Y S1173 D2C2305Y D2E1385Y S1174 D1M1794FY D1M2954FY D1M2984FY S1750K D2E2348Y S176 D2B1886Y S176 D2C1977Y S1768K D1M1759Y D2B2217Y S182 D1L1613Y D2B0177Y S183 D1M1421Y D2E1280Y S184 D1L3136Y D1M2895Y D2D0954Y D2D0964Y D2D0967Y D2D0972Y S185 D2B2785Y D2B2877Y D2B2878Y D2C1421Y D2D0957Y D2D0968Y D2D0971Y D2D0984Y D2D0985Y D2E2680Y D2E2767Y D2E2769Y S187 D2A1585Y S206 D1L2658Y D1M2896Y D2A1586Y S243 D1M1020Y D2D2348Y S244 D1M1590Y S245 D2A0559Y D2C2036Y D2C2162Y D2D1871Y S246 D2E1375Y S2782K D2F0062Y S303 D1M1424Y D2C1472Y D2D1872Y D2D2120Y D2E1496Y S304 D2B0173Y D2C2163Y D2C2805Y D2D1991Y D2E1484Y S305 D1L3282Y D1L3459Y D2C1280Y D2C1281Y D2C1479Y D2D0959Y D2E0907Y D2E2768Y D2E2772Y S316 D1L3311Y D1M0530Y D2A0555Y D2A0557Y D2A0558Y D2A0866Y D2C2806Y D2D2434Y D2D2436Y S317 D2D2087Y D2E0587Y S318 D1M0153Y D2A1677Y S346 D2A0867Y D2B1884Y S605 D1L2686Y D2B2244Y S607 D1M2899Y S608 D1L1617Y D1L1619Y D1L1622Y D1M0173Y D1M0635Y D1M0655Y D2E1210Y SS523 D2C1971Y SS525 D1G1346Y SS5641 D2B2181FY SS5641G D1D2533FY SS5678 D1L2430FY SS5684 D2B1970FY SS623 D1G0960Y D2A1069Y SS645 D1K2457FY D1L3151FY D1M2526FY D1M2531FY SS653 D1E2737FY SS673 D1L0164FY SS683G D1L0794FY SS685G D2A0503FY SS686 D1E0201FY SS689 D2C0024FY SS745 D1M2971FY SS786 D1E1220FY SS787 D1L0032FY VS533 D1M0598Y VS845 D2B1779Y VS870 D1M2873Y VS871 D1L0602Y VS8712 D2C3153Y VS872 D1M1837Y D2C2945Y VS8722 D1D3187Y D1M1292Y VS882 D1G1139Y VS8902 D2B0364Y XX5278 D2B0174Y XX5280 D2E1482Y XX5281 D2B0175Y XX5284 D1L2691Y", "more_code_info": "" } ] }